Clinical trial · Interventional
Expanding Phase III Study of Tyroserleutide for Injection
Randomized, Double-Blind, Placebo-Controlled, Multicenter Expanding Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma (HCC) (After HCC Resection)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions 21 days after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups:6mg/d Tyroserleutide (injection), or placebo
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gan Fu Le Tablets | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Tyroserleutide for injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- the Tyroserleutide for injection
- description
- the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets,6 tablets,po,tid
- interventionNames
- Drug: Gan Fu Le Tablets
- Drug: Tyroserleutide for injection
- type
- PLACEBO_COMPARATOR
- label
- the placebo group
- description
- the placebo Gan Fu Le Tablets,6 tablets,po,tid
- interventionNames
- Drug: Gan Fu Le Tablets
- Drug: Placebo
Primary outcomes (1)
- measure
- OS (Overall Survival)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Aged ≥ 18 years and ≤ 75 years old, male or female * Subject underwent resection of hepatocellular carcinoma (confirmed by pathology) * The tumor characteristics must meet the following:A single tumor with a maximum diameter \>5cm ,Preoperative imaging, or Intraoperative visual observation.; Exclusion Criteria: * Concomitant malignant tumor(s) in other systems is/are present * Tumor thrombosis in the branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery * The subject received any previous systemic anti-HCC therapy prior to the resection surgery (except the resection surgery), such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC therapy * The subject took Sorafenib prior to randomization * The subject took other study/investigational drugs 7 days prior to randomization * The subject took Kang Laike injection/soft capsule,or Jinke Huaier granule 7 days prior to randomization * The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases * The subject has history of investigational drug or similar drug allergy * The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present * The subject is pregnant, lactating, or urine pregnancy test result is positive * Baseline (post-resection) examination exist tumor recurrence or metastasis;
References
Publications (0)
Data not yet available